The European Medicines Agency said Thursday it has recommended authorising the use of the anti-viral drug remdesivir to treat the new coronavirus.
“Remdesivir is the first medicine against COVID-19 to be recommended for authorisation in the EU,” the agency said.
It said the recommendation still needs approval from the European Commission, which is due to make a decision in the coming week.
At least two major US studies have shown that remdesivir can reduce the duration of hospital stays for COVID-19 patients.
Washington authorised the emergency use of the medicine — which was originally intended as a treatment for Ebola — on May 1, followed by several Asian nations including Japan and South Korea.
EMA’s human medicines committee said it has recommended granting a conditional marketing authorisation to remdesivir for the treatment of COVID-19 in adults and adolescents from 12 years of age who are suffering pneumonia and require extra oxygen.
It said its assessment was based mainly based on data from a study sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID).
The research, published in the leading journal the New England Journal of Medicine in May, showed that injections of remdesivir speeded patient recovery compared with a placebo.
On average it reduced patients’ hospital stays from 15 days to 11.
One study published in The Lancet, however, found no “significant clinical benefit” from treating coronavirus patients with remdesivir.
“Taking into consideration the available data, the agency considered that the balance of benefits and risks had been shown to be positive in patients with pneumonia requiring supplemental oxygen; i.e., the patients with severe disease,” the Amsterdam-based EU agency said.